Duns Number:536935331
Device Description: The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define t The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the size of the implant. This model is size 2.
Catalog Number
-
Brand Name
IPP-ON®
Version/Model Number
239022ND
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTO
Product Code Name
REAMER
Public Device Record Key
fdf39476-41f3-43ed-a0b0-6f2d8d85d0b1
Public Version Date
September 20, 2021
Public Version Number
3
DI Record Publish Date
May 26, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |